Kornimate/medical-research-clean huggingface dataset:
tricaprilin phase 2 pilot study in migraine

Conditions: Migraine

Summary: this is a randomised, double-blind, placebo-controlled, parallel-group, multi-centre study of tricaprilin as ac-sd-03 compared with placebo for the reduction of migraine in participants with frequent migraine.


Eligibility criteria:
inclusion criteria: 1. participant must be 18 to 70 years of age inclusive, at the time of signing the informed consent. 2. participants who have frequent (episodic or chronic) migraine with or without aura, for at least 1 year, according to the international classification of headache disorders version 3 beta (ichd 3-beta), age at time of onset must be \<50 years. 3. participants must have a certain number of migraine headaches days per month, as confirmed by the baseline measurement period. 4. use of one allowed migraine prophylactic is permitted if the participant has been on a stable dose for at least 2 months prior to the screening. 5. participants must have failed (no therapeutic response) 1-4 migraine prophylactic treatments. 6. the participant is able to tolerate a 12.5g dose of ac-sd-03 (containing 5g of tricaprilin) as per sentinel dose challenge at the baseline visit. 7. from visit 2 to visit 3 (baseline measurement period), the participant has sufficient compliance (at least 80%) with daily ediary headache entries. exclusion criteria: 1. in the opinion of the investigator, has presence or history of an advanced, severe, progressive, or unstable disease of any type that could interfere with efficacy and safety assessments, or put the participant at risk. 2. use of barbiturates (and/or butalbital-containing analgesics) or opioids (and/or opioid-containing analgesics) for migraine acute treatment ≥ 4 days per month on average and/or in the last month prior to screening visit. 3. use in the last 3 months prior to screening visit of cgrp agents, botox injections, tens, cranial nerve blocks, trigger-point injections, acupuncture, cbd-containing products, infusion therapy. 4. current use, or use within 3 months of visit 2 (baseline), of axona® or other mct-containing products (such as coconut oil). use of mct-containing products is not allowed at any time during trial participation. 5. current use, or use within 3 months prior to screening, of a ketogenic diet, low-carb diet, intermittent fasting (including the 5:2 diet). ketogenic diets, low-carb diet, intermittent fasting (including the 5:2 diet) are not allowed during the study.
development and validation of a web-based nomorgam to predict postoperative complications

Conditions: Gastric Cancer

Summary: the incidence of complications after gastrectomy remains high among elderly patients with gastric cancer. the investigators sought to establish and validate a web-based nomorgam for predicting total complications among elderly patients undergoing resection of gastric cancer.


Eligibility criteria:
inclusion criteria: * diagnosed with gastric cancer by endoscopy or pathology * planned to receive radical surgery for the first time * aged 60 or older exclusion criteria: * received preoperative radiotherapy or chemotherapy * with other sites of malignant tumors

Keywords: gastric cancer;postoperative complications;nomogram
comparison of intravitreal ranibizumab and macular grid-pattern laser for treatment of diabetic macular edema

Conditions: Macular Edema

Summary: this study investigates the hypothesis that ranibizumab injection given into the eye is an efficacious and safe treatment option applied for swelling of the macula (site of sharp vision) in diabetes.

this is a randomized, controlled, three-center trial to assess the efficacy and safety of intravitreal ranibizumab injections in diabetic macular edema. comparator arm consists of patients receiving macular grid-pattern laser therapy.

Eligibility criteria:
inclusion criteria: * male or female type i or ii diabetic patients over 18 years of age * diagnosis of dme secondary to diabetic retinopathy and decrease in vision is due to dme and not due to other causes in the opinion of the investigator * patients who have a bcva score between 78 and 39 letters in the study eye using etdrs-like visual acuity charts at a testing distance of 4 meters * expectation by the investigator that patient will potentially benefit from laser treatment or ranibizumab treatment * willing and able to comply with all study procedures exclusion criteria: * active intraocular inflammation, any active infection or history of uveitis * uncontrolled glaucoma or neovascularization of the iris in the study eye * structural damage within 0.5 disc diameter of the center of the macula in the study eye likely to preclude improvement in visual acuity following the resolution of macular edema, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s), epiretinal membrane involving fovea or organized hard exudate plaques * concurrent disease in the study eye that could compromise visual acuity or prevent the improvement of visual acuity (including diabetic proliferative retinopathy) or require medical or surgical intervention during the study period, including cataract, retinal vascular occlusion, retinal detachment, macular hole or choroidal neovascularization of any cause * panretinal laser photocoagulation in the study eye within 6 months prior to or during the study or focal/grid laser photocoagulation in the study eye within 3 months prior to study entry * treatment with anti-angiogenic drugs (pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc) or intravitreal corticosteroids in the study eye within 3 months prior to randomization * any intraocular surgery in the study eye within 3 months prior to randomization * history of vitrectomy in the study eye * ocular conditions in the study eye that require chronic concomitant therapy with topical ocular or systemically administered corticosteroids * pregnancy and lactation
vitamin d deficiency and low bone mineral content in children

Conditions: Vitamin D Deficiency; Obesity

Summary: the vitamin d study is designed to investigate the effect of body fat mass on vitamin d levels in children. earlier studies have shown that individuals with increased fat mass may have low vitamin d levels. our specific hypothesis states that children with increased fat mass will have lower blood levels of vitamin d when compared to non-obese children.since vitamin d is the primary hormone for bone mineralization in humans, low levels of vitamin d could lead to decreased bone mineral content in these children.

fifty prepubertal male and female children of ages between 3-12 years will participate in this study. of these, 25 obese children will be enrolled in the study group, and 25 non-obese children will serve as controls. all subjects will fill out a comprehensive mineral intake questionnaire as part of the study to ensure adequate calcium intake prior to the study. all subjects will collect a first morning urine sample for calcium, creatinine, and ntx. fasting blood samples will be drawn for the following analytes: 25-hydroxyvitamin d, 1, 25-dihydroxyvitamin d, intact pth, calcium, phosphorus, magnesium, osteocalcin, insulin, c-peptide, fasting blood glucose, leptin, and adiponectin. bone mineral content will be evaluated in 16 obese subjects with vitamin d level of \< 30 nmol/l.

Eligibility criteria:
inclusion criteria: * general: prepubertal children (males, with testicular volume of ≤ 3 cc, and girls with tanner 1 breast) of ages 7-11 years will be enrolled in the study. * study group: subjects with a bmi of \> 95th percentile for age and sex. * control group: all control subjects will have a bmi of \< 85th percentile for age and sex. exclusion criteria: * known metabolic or genetic diseases resulting in obesity such as severe hypothyroidism, pseudohypoparathyroidism, or cushing's disease * diabetes mellitus * subjects on lipid lowering medications * subjects on medications known to impact body weight or calcium homeostasis * subjects with a history of recent significant weight loss or gain

Keywords: vitamin d deficiency, insulin resistance, obesity, bone
energy expenditure responses to acute exercise in older women (calorie expenditure and exercise)

Conditions: Aging

Summary: in older, normal-weight women (60-75 yrs, bmi=18-28 kg/m2), an acute bout of higher-intensity (60% of maximum effort) aerobic exercise, in comparison to an isocaloric bout of lower-intensity (45% of maximum effort) exercise (caloric expenditure of 3.5 kcal/kg body weight for both), will result in differential: 1. decline in non-exercise activity calorie expenditure in the subsequent 48 hours after exercise; 2. increase in resting metabolic rate 48 hours after exercise; 3. increase in serum free triiodo-l-thyronine (free t3) concentrations immediately following exercise; 4. decline from pre-exercise in plasma leptin and serum free t3 concentrations 48 hours after exercise.


Eligibility criteria:
inclusion criteria: 1. women 2. age 60-75 years 3. normal weight 4. weight-stable (± 5%) within the previous 3 months 5. non-smoking for last year 6. able to provide own transportation to study visits 7. not currently involved in any other research study 8. willing and able to participate in all aspects of the trial including research testing 9. willing to give informed consent to participate exclusion criteria: 1. self-reported significant cardiovascular disease 2. other self-reported medical conditions such as diabetes, chronic or recurrent respiratory conditions, active cancer, musculoskeletal disease 3. medications known to affect exercise performance or metabolism 4. excess caffeine use (\> 500mg/day) 5. any self-reported contraindications to exercise 6. clinical depression 7. abnormal cognitive function -

Keywords: older neat exercise rmr energy expenditure
evaluation of a power assistance device for wheelchair-duo

Conditions: Paraplegia; Hemiplegia

Summary: power assisted wheelchairs have specific advantages compared to manual propelled or powered wheelchair. autonomad mobility has developed a new device (duo), the assistance being triggered by the motion of the wheelchair and not an push on the hand rim, people who use their foot to move or people pushing the wheelchair can be helped by the device as people propelling the wheelchair with their arms. furthermore duo has an option with a longer assistance (aep+) which can be preferred by some people. to be referenced and reimbursed by the french health insurance, duo has to be compared with an other power assistance device for wheelchairs, already referenced. the study is a comparative study between duo and the alber e motion. each patient is his own control and is assessed in 4 experimental conditions, with intervals of 3 or 4 days, manually propelled, with the e mtion device, with the duo device and the single push configuration, with the duo device and the aep+ configuration. the main outcome measure will be the user's satisfaction (using 8 items of the esat questionnaire)


Eligibility criteria:
inclusion criteria: * with a motor deficiency (of any origin) needing a manual wheelchair * propelling his wheelchair with both arms or with one foot and one arm. * covered by the french national health insurance. * living at less than 30km form the investigation center exclusion criteria: * subject of a guardianship or tutelage measure * owning already a power wheelchair or a powered assisted wheelchair * with cognitive impairments that affect the steering capacity or the understanding of the instructions. * patient unable to use a manual wheelchair indoor without help, * contraindication in keeping a seating position especially the occurrence of ulcers.

Keywords: power assistance device wheelchair
antibiotic strategy and asymptomatic bacteriuria in the context of intra-vesical botulinum toxin a injections.

Conditions: Urinary Tract Disease

Summary: the study aims to demonstrate that the "thrifty antibiotic strategy" applied to ms or sci patients with asymptomatic bacteriuria prior to bonta intravesical injections does not increase the rate of symptomatic post-injection utis compared to the current peri-operative antibiotic strategy. patients included in the study will be randomized in two balanced-parallel groups, 4 days (+/- 2 days) before intra-vesical bonta injections. group 1: experimental group: "sparing antibiotic strategy" no antibiotic therapy will be administered during the peri-operative period. group 2: control group: recommendations - peri-operative antibiotic strategy an antibiotic therapy will be administered during the peri-operative period. the antibiotic will be selected according to the type of bacteria isolated and the antibiotic susceptibility testing, and started two days before and pursued until two days following intra-vesical bonta injections. the main objective is to demonstrate the non-inferiority of "antibiotic saving strategy" compared to peri-operative antibiotic strategy (current recommendations) for occurrence of symptomatic uti after intra-vesical bonta injections in the management of asymptomatic bacteriuria (ab) among multiple sclerosis (ms) and spinal cord injured (sci) patients undergoing clean intermittent self-catheterization (cisc).


Eligibility criteria:
inclusion criteria: * ms or sci (traumatic or non-traumatic) * refractory oab and/or do (failure, intolerance or contra-indication to anti-muscarinic therapy) * treated with intra-vesical botulinum toxin a injections having proved efficacy * cisc as the exclusive bladder management * ab on pre-operative urine analysis (performed 10 days (+/- 2 days) before intra-vesical bonta injections) * exclusion of morphologic urinary tract abnormalities considered as a risk factor for recurrent symptomatic uti. exclusion criteria: * having already participated to the study * augmentation cystoplasty * bladder compliance disorders (\<20 ml/cmh2o) * ongoing cyclic antibiotic therapy * ongoing corticosteroid therapy * modification of immunosuppressive or immunomodulatory therapy in the 3 months before inclusion (ms patients) * antibiotic therapy in the month before inclusion * surgical procedure in the 3 months before and the 6 weeks following inclusion * symptomatic uti at the time of inclusion * associated neurologic disease * pregnancy or breast feeding * individuals especially in need of protection * no informed consent * patients incapable to follow the trial, e.g. because of language problems, psychiatric disorders, dementia and so on * immunocompromised patients

Keywords: neurogenic lower urinary tract dysfunction clean intermittent self catheterization asymptomatic bacteriuria botulinum toxin a sparing antibiotic strategy safety
orbital vessel preparation to maximize dcb efficacy in calcified below the knee (btk) lesions - a pilot study

Conditions: PAD; Vascular Calcification

Summary: the purpose of this study is to prospectively evaluate acute and long term clinical results of orbital atherectomy (oa) with adjunctive drug coated balloon (dcb) angioplasty versus dcb angioplasty alone for treatment of peripheral artery disease (pad) in below the knee (btk) lesions.


Eligibility criteria:
inclusion criteria: * subject's age ≥ 18 years * rutherford clinical category 3 - 5 * lesions \[except in-stent restenosis (isr)\] of the distal popliteal (pop segment below the anatomical knee joint), anterior tibial, posterior tibial, tibial peroneal trunk, and peroneal arteries with ≥ 70 % diameter stenosis (ds) by angiography * presence of clearly visible calcification in two views (both sides of vessel at the same location) evaluated angiographically- \[computerized tomography (ct) angio images may substitute to confirm distribution of calcium, if available as standard of care\] * length of calcium ≥ 25 % of total lesion length or ≥ 2 cm total length * target lesion length up to 20 cm exclusion criteria: * subject or subject's legal representative is not willing to sign an ethics committee approved informed consent form or comply with the study protocol requirements * contraindicated by either device, per instructions for use * presence of inflow lesion (≥ 50 % ds) or inflow not successfully treated (≥ 50% ds and/or unresolved significant angiographic complication) * compromised outflow distal to the target lesion (≥ 70 % ds) or presence of lesion(s) or occlusion(s) located from 5 cm above the ankle to below the ankle joint space * subject has more than 2 target vessels requiring treatment * the guide wire cannot be passed across the target lesion(s) and/or guide wire position distal to target lesion(s) outside vessel lumen * presence of significant (≥ 70 % ds) lesion(s) or occlusion(s) not meeting the study criteria which were not successfully treated during the index procedure (≥ 50 % ds and/or significant angiographic complication) * subject has planned amputation (including minor) of the index limb or previous major amputation of the contralateral limb * creatinine \> 2.5 mg/dl, unless on dialysis * subject has any significant medical condition which, in the investigator's opinion, may interfere with the subject's optimal participation in the study * subject is participating in an investigational drug or device study that has the potential to clinically interfere with the study outcome measures * subject is pregnant or planning to become pregnant within the study period * subject has an unresolved severe systemic infection * subject has an anticipated life span of less than one year * subjects with known hypersensitivity to paclitaxel or paclitaxel related compounds * subjects who cannot receive recommended anti-platelet and/or anticoagulant therapy * pre-dilatation of the target lesion prior to randomization and oa treatment

Keywords: drug-coated balloons calcified lesions orbital atherectomy below the knee paclitaxel lutonix 014 drug-coated balloon
nevirapine (nvp) use to prevent mother-to-child transmission of hiv

Conditions: HIV Infections

Summary: hiv can be transmitted from an hiv infected mother to her infant through her breast milk. the purpose of this study is to determine whether giving infants of hiv infected mothers the anti-hiv drug nevirapine (nvp) for six weeks will reduce the risk of hiv transmission. study hypothesis: six weeks of nevirapine prophylaxis provided to the infant will decrease hiv transmission through breastfeeding.

the use of antiretroviral therapy during late pregnancy, intrapartum, and immediately postpartum prevents a high proportion of vertical transmission. potential means of decreasing hiv transmission through breastfeeding, along with the risks and benefits of early weaning, need to be further evaluated. the potential impact of early weaning interventions on the breastfeeding habits of the hiv uninfected population needs to be considered as well. this study seeks to identify a way to make breastfeeding safe for hiv infected women who choose to breastfeed. a single dose of nvp given to infants of hiv infected mothers appears to provide some protection against vertical transmission. nvp's long half-life allows simple dosing, making it more feasible and affordable to implement in a developing country. this study will determine whether extending the nvp dosing to six weeks will significantly decrease transmission during the first several months of breastfeeding.

Eligibility criteria:
inclusion criteria: * hiv infection, documented on two separate specimens * estimated gestational age at enrollment of 32 weeks or more as indicated by last menstrual cycle and fundal height * permanent residency in addis ababa * plan to deliver at a hospital affliated with the study (tikur anbessa hospital, gandhi hospital, or st. paul's hospital) * hemoglobin \>= 7.5 gm/dl within 4 weeks prior to study entry * serum glutamic pyruvic transaminase (sgpt) \< 5 times upper limit of normal within 4 weeks prior to study entry * serum creatinine \< 1.5 mg/dl within 4 weeks prior to study entry * consent form signed by the mother and, when possible, by the father, prior to the onset of labor

Keywords: maternal/infant transmisson vertical transmission pregnancy hiv seronegativity
clustering among the clinical profiles of patients with pectus excavatum

Conditions: Funnel Chest

Summary: the primary objective of this study is to describe the relative distances between patient clinical profiles (i.e. patient clustering) in multivariate space.

observational data will be collected from patient files and submitted to clustering analyses. then clusters will be compared.

Eligibility criteria:
inclusion criteria: * adult patient with pectus excavatum * the patient has had corrective surgery exclusion criteria: * the patient has expressed opposition to the study

Keywords: pectus excavatum
radiofrequency in the treatment of urinary incontinence after radical prostatectomy

Conditions: Urinary Incontinence; Post Prostatectomy

Summary: post-prostatectomy urinary incontinence (iupp) is a difficult to treat complication that causes a profound negative impact on the individual's quality of life, as well as seriously disrupts the physician-patient relationship and is a substantial public health problem . urinary incontinence (ui) can occur both in the treatment of benign prostatic hyperplasia (bph) and in the treatment of prostate cancer. in the treatment of benign disease, this complication is associated with a very low prevalence, initially of 9% and about 1% in 12 months postoperatively. in radical prostatectomy, the prevalence is higher, varying from 2% to 87%, depending on the populations and sites studied, the definitions used, the different methodologies employed in the evaluation of incontinence, and also the different degrees of intensity of the disease . several authors have evaluated the incidence of incontinence after robotic radical prostatectomy, open and laparoscopically. with these techniques, the reported total ui incidence varies from 4% to 40% . with the high prevalence of iupp, accelerating the recovery of urinary control is an important priority for patients and their caregivers, and the search for effective and low-risk treatments is a constant. thus, the possibility of treatment with the radiofrequency (rf) feature arises.

a current treatment proposal is the use of radiofrequency, which is a diathermic process generated by the radiation of an electromagnetic spectrum, resulting in an immediate retraction of existing collagen and subsequent activation of fibroblasts causing a neocollagenesis. in studies using radiofrequency to treat sui, a therapeutic response to 50% was shown. representing a more cost-effective treatment than surgery.

Eligibility criteria:
inclusion criteria: * will be individuals from 18 to 65 years of age with clinical complaints of urinary incontinence after prostatectomy and who agree to voluntarily participate in the research. exclusion criteria: * will be excluded from the study the patients with time less than 45 days postoperative, difficulty understanding the proposed instruments, patients with neurological degenerative chronic diseases, patients with implantable cardioverter defibrillators and carriers of iatrogenic metals in the pelvic region.
combined chelation therapy in patients with transfusion dependent thalassemia and iron overload

Conditions: Thalassemia; Iron Overload

Summary: this is a pilot study looking at the safety and efficacy of giving combination chelation with deferasirox and deferoxamine. the hypothesis is that combination chelation is safe in decreasing overall iron in patients with thalassemia.

this was a phase two pilot clinical trial designed to evaluate the safety and efficacy of the combination of deferasirox and deferoxamine in transfusion dependent thalassemia with a range of systemic iron burden. the duration of combined therapy was 12 months. changes in liver iron concentration, ferritin, myocardial iron, and serum creatinine was monitored.

Eligibility criteria:
inclusion criteria: * transfusion dependent thalassemia * if iron between 5-15 mg/g dry liver by squid, subject must have a documented endocrinopathy or cardiac finding * older than 8 years exclusion criteria: * participating on another interventional clinical trial

Keywords: thalassemia chelation iron overload thalassemia patients with iron overload